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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00545961
Other study ID # Diary nr 41/2007
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received October 17, 2007
Last updated October 18, 2007
Start date November 2007
Est. completion date December 2009

Study information

Verified date October 2007
Source Oulu University Hospital
Contact Aila A Kristo, MD
Phone +35883153492
Email aila.kristo@ppshp.fi
Is FDA regulated No
Health authority Finland: Finnish Medicines Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to find out whether the children with respiratory infection and the presence of pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the nasal middle meatus benefit from antimicrobial treatment.


Description:

Acute sinusitis is one of the most common disease in children requiring antimicrobial treatment. The diagnosis and treatment outcomes of acute sinusitis are contradictory, and better diagnostic criteria are needed. In adults with acute maxillary sinusitis, bacterial culture results obtained from the nasal middle meatus are comparable to those obtained from sinus puncture and aspiration. In children, the presence of pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the nasal middle meatus during respiratory infection predicts longer duration of signs and symptoms of common cold.

In this randomized placebo-controlled study, the effect of the antimicrobial treatment (amoxicillin-clavulanate) is examined in children with pathogenic bacteria (S. pneumoniae, H. influenzae or M. catarrhalis) in the nasal middle meatus during respiratory infection. The duration of the symptoms and speed of recovery is recognized by daily symptom-diary, the results are compared between the treatment groups.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date December 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 13 Years
Eligibility Inclusion Criteria:

- acute respiratory infection with nasal symptoms (nasal obstruction or discharge)

- seeking medical help from health centre for the respiratory symptoms

- pathogenic bacteria (S pneumoniae, H influenzae or M catarrhalis) identified from right or left nasal middle meatus in the endoscopically taken swab culture sampling taken by a study investigator (all microbiological analyses are done by the National Public Health InstituteĀ“s microbiological laboratory in Oulu)

Exclusion Criteria:

- otitis, tonsillitis or other disease requiring antimicrobial treatment

- respiratory infection within 4 weeks of screening

- antimicrobial treatment within 4 weeks of screening

- allergy to penicillin or amoxicillin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
placebo
mixture, 0.28125 ml/kg twice a day for 7 days
amoxicillin clavulanate acid
mixture 0.28125 ml / kg twice a day for 7 days

Locations

Country Name City State
Finland Keski-pohjanmaan keskussairaala Kokkola
Finland Oulu University Hospital Oulu
Finland Etelä-Pohjanmaan Keskussairaala Seinäjoki

Sponsors (1)

Lead Sponsor Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of continuous daily symptoms of the acute respiratory infection diagnosed at the study entry. within the first 3 weeks after enrolment
Secondary duration (days)and severity (grade mild, severe) of different symptoms (clear nasal discharge, coloured nasal discharge, nasal obstruction, cough, throat pain, ear ache, fever, headache, diarrhea) within the first three weeks after enrolment
Secondary number of days the child is using the following symptomatic drugs (pain killers, nasal vasoconstrictors, nasal corticosteroids, asthma drugs, antihistamines) within the first three weeks after the enrolment
Secondary number of days the child is not at school and that the parents are not at work within the first three weeks after enrolment
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